United StatesThe Large Volume Pump (LVP) of the Ivenix Infusion System (model LVP-0004, UDI-DI 00811505030320) sold by Fresenius Kabi USA and installed in 18,444 units distributed nationwide in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI is affected. It was recalled because of the potential for the Cassette Loading Lever to break.
What's being recalled
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Recalling firm: Fresenius Kabi USA, LLC, North Andover, MA, United States.
How to identify it
Model Number: LVP-0004. UDI-DI: 00811505030320
The hazard
Potential for the Cassette Loading Lever to break.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)